Revisiting Canada's Access to Medicines Regime in Response to COVID-19: A Review of the Legislation and its Underlying Objectives

The current COVID-19 pandemic has highlighted the significance of the export-oriented compulsory licensing mechanism for countries lacking domestic manufacturing capacity. Article 31bis, the first amendment to the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), is aimed at giving effect to the WTO General Council Decision 2003, which waived the domestic market requirement of compulsory licensing. In 2005, Canada became the first country to amend its patent laws to provide for Canada’s Access to Medicines Regime (CAMR) as enabling legislation to implement the WTO General Council Decision 2003. Canada clearly described its regime as a humanitarian initiative aimed at helping least-developed countries and many developing countries that lack sufficient drug and/or vaccine manufacturing capacity of their own and rely upon imports to address their public health problems. The legislation got compromised by the conflicting goals of protecting the corporate interests of patentee corporations. This research paper argues that the CAMR system is not capable of delivering what was promised. This research paper maintains that Canada unnecessarily added extra layers of complication, restrictions, and regulatory requirements on top of what was required under Article 31bis, which is itself too onerous to invoke for resource-poor countries. This research paper also evaluates Canada’s efforts to reform CAMR and suggests overhauling of export-oriented compulsory licensing mechanism to provide a functional and expeditious one-licence solution workable for importing countries and acceptable to generic drug companies.